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Acute Evaluation of the Safety of Left Ventricular-left Ventricular (LV-LV) Delays and Its Effects on Mechanical Dyssynchrony

Sponsor
Abbott Medical Devices (Industry)
Overall Status
Completed
CT.gov ID
NCT01044784
Collaborator
(none)
73
Enrollment
1
Location
24.9
Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effects of various LV-LV delays during multi-site left ventricular (MSLV) pacing on mechanical dyssynchrony in cardiac resynchronization therapy (CRT) patients post-implant.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    73 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Acute Evaluation of the Safety of LV-LV Delays and Its Effects on Mechanical Dyssynchrony
    Study Start Date :
    Feb 1, 2010
    Actual Primary Completion Date :
    Mar 1, 2012
    Actual Study Completion Date :
    Mar 1, 2012

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      1. Have an approved indication for a CRT implant

      2. Undergoing or previously received the implant of a St. Jude Medical Promote Q 3221-36 CRT-D with a Quartet Model 1458Q LV lead at participating clinical study site

      3. Ability to provide informed consent for study participation and be willing and able to comply with the prescribed evaluations

      Exclusion Criteria:

      1. Have persistent or permanent atrial fibrillation

      2. Have an intrinsic heart rate of <50 beats per minute

      3. Have Cheyne-Stokes breathing

      4. Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures

      5. Have had a recent CVA or TIA within 3 months prior to enrollment

      6. Be less than 18 years of age

      7. Be pregnant

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Schuchtermannklinik Bad Rothenfelde Germany

      Sponsors and Collaborators

      • Abbott Medical Devices

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Abbott Medical Devices
      ClinicalTrials.gov Identifier:
      NCT01044784
      Other Study ID Numbers:
      • 60028011
      First Posted:
      Jan 8, 2010
      Last Update Posted:
      Jul 8, 2020
      Last Verified:
      Jul 1, 2020
      Studies a U.S. FDA-regulated Drug Product:
      No
      Studies a U.S. FDA-regulated Device Product:
      No
      Keywords provided by Abbott Medical Devices
      CRT

      Study Results

      No Results Posted as of Jul 8, 2020